What the label lists and what reports show
Iptacopan side effects
Iptacopan's FDA label: “Most common adverse reactions in adults with PNH (incidence ≥ 10%) were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea and rash.” FAERS holds 730 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (87 reports).
- No generic listed
- Boxed warning
Check it at the source: the iptacopan FDA label on DailyMed (effective July 16, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FABHALTA?FABHALTA may cause serious side effects, including: See “What is the most important information I should know about FABHALTA?” Increased cholesterol and triglyceride (lipid) levels in your blood. Your healthcare provider will do blood tests to check your cholesterol and triglycerides during treatment with FABHALTA. Your healthcare provider may start you on a medicine to lower your cholesterol if needed. The most common side effects of FABHALTA in adults include: headache nasal congestion, runny nose, cough, sneezing, and sore throat (nasopharyngitis) diarrhea feeling dizzy pain in the stomach (abdomen) infections (bacterial and viral) nausea rash Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of FABHALTA. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 16, 2026 (SPL set a76b5845-6e21-4d3b-ad07-cd8df1b60bee), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adults with PNH (incidence ≥ 10%) were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea and rash.
Table 1: Adverse Reactions Reported in > 5% of Patients Treated with FABHALTA in APPLY-PNH or APPOINT-PNH Studies (24-Week Treatment Period)
| Reaction | Adverse reactions FABHALTA (N = 62) n (%) | APPLY-PNH Anti-C5 (Eculizumab or Ravulizumab) (N = 35) n (%) | APPOINT-PNH FABHALTA (N = 40) n (%) |
|---|---|---|---|
| Headache a | 12 (19) | 1 (3) | 11 (28) |
| Nasopharyngitis b | 10 (16) | 6 (17) | 6 (15) |
| Diarrhea | 9 (15) | 2 (6) | 3 (8) |
| Abdominal pain a | 9 (15) | 1 (3) | 3 (8) |
| Bacterial infection c | 7 (11) | 4 (11) | 2 (5) |
| Nausea | 6 (10) | 1 (3) | 2 (5) |
| Viral infection d | 6 (10) | 11 (31) | 7 (18) |
| Arthralgia | 5 (8) | 1 (3) | 0 |
| Thrombocytopenia a | 4 (6) | 0 | 0 |
| Dizziness | 4 (6) | 0 | 1 (3) |
| Systemic hypertension a | 4 (6) | 0 | 0 |
| Lipid disorder e | 4 (6) | 0 | 3 (8) |
| Rash f | 2 (3) | 0 | 4 (10) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections Caused by Encapsulated Bacteria [see Warnings and Precautions (5.1)]. Hyperlipidemia [see Warnings and Precautions (5.4)]. Most common adverse reactions in adults with PNH (incidence ≥ 10%) were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea and rash. ( 6.1 ) Most common adverse reactions in adults with IgAN (incidence ≥ 5%) were abdominal pain and dizziness. ( 6.1 ) Most common adverse reactions in adults with C3G (incidence ≥ 10%) were nasopharyngitis and viral infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 16, 2026 (SPL set a76b5845-6e21-4d3b-ad07-cd8df1b60bee), via openFDA; the full label on DailyMed
What do FAERS reports show?
730 reports list iptacopan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 44 are coded as a death and 171 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Iptacopan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions